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Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer

NCT02046538 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-25

No results posted yet for this study

Summary

The purpose of this study is to establish the safety of Zaltrap in patients who undergo pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my impact colorectal cancer growth and metastasis.

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum

Interventions

DRUG

Leucovorin

400 mg/m2 IV over two hours (or administered concurrently with oxaliplatin or irinotecan, depending on the assigned regimen)

DRUG

Oxaliplatin

85 mg/m2 IV over two hours

DRUG

5-FU

400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours

DRUG

Irinotecan

180 mg/m2 IV over 90 minutes

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Manish A. Shah, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-02-29
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046538 on ClinicalTrials.gov